Bayer Affirms Benefit-Risk Profile of Its Oral Contraceptives

Established body of well grounded data show VTE risk comparable
in combined oral contraceptives studied

WAYNE, N.J.,
April 21, 2011 /PRNewswire/ -- Bayer
HealthCare Pharmaceuticals, Inc. is aware of two studies published
today in The British Medical Journal, ONLINE FIRST. These
papers are "Risk of venous thromboembolism in users of oral
contraceptives containing drospirenone or levonorgestrel: nested
case-control study based on UK General Practice Research Database"
by Lianne Parkin et al(1); and "Risk
of non-fatal venous thromboembolism in women using oral
contraceptives containing drospirenone compared with women using
oral contraceptives containing levonorgestrel: case-control study
using United States claims data"
by Susan S. Jick et al(2).

Bayer's assessment, based on its review to date, is
that the manner in which the authors applied the study methodology
reported in these two publications and the databases used provide
less reliable conclusions than are available from existing
scientific evidence around the risk of developing venous
thromboembolism (VTE), or blood clots, with combination oral
contraceptives (COCs). Given the already large and robust
scientific body of evidence, in Bayer's opinion, these studies do
not change the overall assessment about the safety of Bayer's oral
contraceptives. Bayer re-affirms that the overall body of
available scientific evidence continues to provide support that the
risk of developing venous thromboembolism (VTE), or blood clots, in
women using drospirenone-containing combination oral contraceptives
(COCs) is comparable to other combination birth control pills
studied.

"Bayer has sponsored several independently-conducted,
large-scale, prospective, observational safety studies on the use
of combined oral contraceptives (COCs), including the EURAS(3)
Study and LASS(4) follow up study, the Ingenix(5) Study and the
INAS(6) Study" said Leo Plouffe, MD,
Vice President, US Medical Affairs, Women's HealthCare, Bayer
HealthCare Pharmaceuticals. "Bayer's assessment that its
drospirenone-containing COCs are safe and effective when taken as
directed according to prescribing information is supported by
consistent clinical findings over a 15 year period and up to 10
years of post-marketing study results which support that the risk
of VTE is similar with any COC studied, regardless of the
progestin."

Combination oral contraceptives are among the most
systematically studied and widely-used medicines available today.
Bayer's combined oral contraceptives have been and continue
to be extensively studied worldwide.

The above referenced study protocols have been reviewed
by regulatory authorities in both Europe (EMA) and the USA (FDA). They have also been
acknowledged by many experts in the field as among the most
comprehensive and best-designed studies of their kind. These
studies continue to build on a large established body of
well-grounded data about the safety of oral contraceptives with
study designs that allow for control of key confounding factors and
minimize the risk of bias. Importantly, data from these
studies have consistently shown that the risk of VTE with
drospirenone is comparable to that seen with other progestins,
including levonorgestrel.

"The EURAS and Ingenix studies are already reflected in
an April 2010 FDA-approved US label
update for YAZ® (3 mg drospirenone / 0.02 mg ethinyl
estradiol) and Yasmin® (3 mg drospirenone/ 0.03 mg ethinyl
estradiol)," Dr. Plouffe continued. "As science has developed, so
too has the need and demand for more detailed information and
methods that help us control for confounders. With the EURAS
and INAS Studies, we had the right mechanism in place to observe
the risk of VTE in a controlled environment, thus affirming that
VTE risk is comparable across any combined oral contraceptives
studied, with similar dosages of a progestin."

All birth control pills, including Bayer's, carry an
increased risk of blood clots, stroke and heart attack. These
serious side effects are rare. Oral contraceptives increase
the tendency to develop strokes (stoppage or rupture of blood
vessels in the brain) and heart attacks (blockage of blood vessels
in the heart). Blood clots (venous thrombosis) and blockage of
blood vessels are a serious side effect of taking oral
contraceptives. VTE is an uncommon event among women using
combined oral contraceptives, and pregnancy increases the risk of
VTE as much or more than the use of COCs.

Women should not use YAZ or Yasmin if they smoke and
are over age 35. Smoking increases the risk of serious side
effects from the Pill, which can be life-threatening, including
blood clots, stroke or heart attack. This risk increases with
age and number of cigarettes smoked.

Women should not use YAZ or Yasmin if they have kidney,
liver, or adrenal disease because this could cause serious heart
and health problems, or if they have or have had blood clots,
certain cancers, history of heart attack or stroke, or if they are
or may be pregnant. YAZ and Yasmin increase the risk of
serious conditions including blood clots, stroke and heart attack.
Smoking increases these risks, especially in women over 35.
The risk of blood clots is highest during the first year of
use.

In addition, YAZ and Yasmin contain drospirenone, a
different kind of hormone that for some may increase potassium too
much. Therefore, women should not take YAZ or Yasmin if they have
kidney, liver, or adrenal disease because this could cause serious
heart and health problems. Women who are on daily, long-term
treatment for a chronic condition with medications that may also
increase potassium (see below), should consult with their
healthcare provider as they should have a blood test to check their
potassium level during the first month of taking YAZ or Yasmin.

Important Safety Information AboutYAZ®

What is YAZ® prescribed for?

For women who choose the Pill for birth control, YAZ is
approved to:

Prevent pregnancy - 99% effective when taken as
directed

Treat premenstrual dysphoric disorder (PMDD)

YAZ is not approved to treat Premenstrual Syndrome (PMS), a
less serious set of symptoms occurring before your period

Treat moderate acne in women at least 14 years of age

Who should not take YAZ?

Women should not use YAZ if they smoke and are over
age 35. Smoking increases the risk of serious side effects from the
Pill, which can be life-threatening, including blood clots, stroke
or heart attack. This risk increases with age and number of
cigarettes smoked.

Women should not use YAZ if they have kidney, liver, or
adrenal disease because this could cause serious heart and health
problems, or if they have or have had blood clots, certain cancers,
history of heart attack or stroke, or if they are or may be
pregnant.

What are the most serious risks of taking
YAZ?

YAZ increases the risk of serious conditions including
blood clots, stroke, and heart attack. The risk of blood clots is
highest during the first year of use. This risk is greatest
when first starting the Pill and when restarting the same or a
different Pill after a 4 week or greater break.

In addition, YAZ contains drospirenone, a different
kind of hormone that for some may increase potassium too much.
Women should consult their healthcare provider if they are on daily
long-term treatment for a chronic condition with medications that
may also increase potassium (see below), as they should have a
blood test to check their potassium level during the first month of
taking YAZ.

In the contraception and moderate acne clinical trials,
the most common side effects were headache/migraine, menstrual
irregularities, nausea/vomiting, breast pain/tenderness, and mood
changes.

In the PMDD clinical trials, the most common side
effects were menstrual irregularities, nausea, headache, breast
tenderness, fatigue, irritability, decreased libido, weight gain,
and mood changes.

YAZdoes not protect against HIV infection
(AIDS) or other STDs.

You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

Please see full Prescribing Information about YAZ,
including boxed warning, available at http://yaz-us.com/.

Important Safety Information about SAFYRAL™
and YASMIN®

SAFYRAL (drospirenone/ethinyl estradiol/levomefolate
calcium tablets and levomefolate calcium tablets) and YASMIN
(drospirenone 3 mg /ethinyl estradiol 0.03 mg) are associated with
increased risks of several serious side effects, including blood
clots, stroke, and heart attack. Women, especially those 35 and
over, are strongly advised not to smoke because it increases these
risks. In addition, SAFYRAL and YASMIN contain drospirenone, a
different kind of hormone that for some may increase potassium too
much.

What are SAFYRAL™ and YASMIN® prescribed
for?

Available by prescription only, for women who choose
the Pill for birth control, SAFYRAL and YASMIN are approved to:

Prevent pregnancy — 99% effective when taken as
directed

SAFYRAL is also approved for women who choose the Pill
for birth control to:

Provide a daily dose of folate supplementation, which is
recommended for women in their reproductive years. Folate lowers
the risk of having rare neural tube birth defects in a pregnancy
occurring during use or shortly after stopping.

Important Safety Information About SAFYRAL and
YASMIN, Including Boxed Warning

Who should not take SAFYRAL or YASMIN?

Do not use SAFYRAL or YASMIN if you smoke and are
over age 35. Smoking increases your risk of serious side effects
from the Pill, which can be life-threatening, including blood
clots, stroke or heart attack. This risk increases with age and the
number of cigarettes smoked.

Do not use SAFYRAL or YASMIN if you have kidney, liver
or adrenal disease because this could cause serious heart and
health problems, or if you have or have had blood clots, certain
cancers, a history of heart attack or stroke, or if you are or may
be pregnant.

What are the most serious risks of taking SAFYRAL
and YASMIN?

SAFYRAL and YASMIN increase the risk of serious
conditions, including blood clots, stroke and heart attack. The
risk of blood clots is highest during the first year of use.

In addition, SAFYRAL and YASMIN each contain
drospirenone, a different kind of hormone that for some may
increase potassium too much. Consult your healthcare provider if
you are on daily, long-term treatment for a chronic condition with
medications that may also increase potassium (see below), as you
should have a blood test to check your potassium level during the
first month of taking SAFYRAL or YASMIN.

In contraception and folate clinical trials, the most
common side effects were premenstrual syndrome, headache/migraine,
breast pain/tenderness/discomfort, nausea/vomiting and abdominal
pain/discomfort/tenderness.

SAFYRALandYASMINdo not protect against HIV infection
(AIDS) or other STDs.

You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based
pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of
Bayer AG. Bayer HealthCare is one of the world's leading,
innovative companies in the healthcare and medical products
industry, and combines the activities of the Animal Health,
Consumer Care, Diabetes Care, and Pharmaceuticals divisions.
As a specialty pharmaceutical company, Bayer HealthCare
Pharmaceuticals provides products for Diagnostic Imaging, General
Medicine, Hematology, Neurology, Oncology and Women's Healthcare.
The company's aim is to discover and manufacture products
that will improve human health worldwide by diagnosing, preventing
and treating diseases.

This news release may contain forward-looking
statements based on current assumptions and forecasts made by Bayer
Group or subgroup management. Various known and unknown risks,
uncertainties and other factors could lead to material differences
between the actual future results, financial situation, development
or performance of the company and the estimates given here. These
factors include those discussed in Bayer's public reports which
are available on the Bayer website at www.bayer.com. The company assumes no
liability whatsoever to update these forward-looking statements or
to conform them to future events or developments.

(1) Lianne Parkin senior
lecturer in epidemiology and Katrina
Sharples, senior lecturer in biostatistics of the Department
of Preventive and Social Medicine, Dunedin School of Medicine,
University of Otago, New Zealand;
and Rohini K. Hernandez,
epidemiologist and Susan S. Jick,
director, Boston Collaborative Drug Surveillance Program,
Boston University School of Medicine,
Lexington, Massachusetts, USA